Review by Joseph Ross – 03/23/2016 – 3:20pm

Data Request Number: 2016-0774 Recommendation for this data request: Not Approve

The proposal describes an analysis of 4 separate trials that studied the use of epogen for trauma patients. However, only 2 trials are being requested. The requesters need to clarify what 2 additional trials are being used in the analysis, if the trials will be requested via YODA or obtained through other means and uploaded to the SAS platform, and whether these 2 additional trials have all necessary data to complete the analyses.